A Study of Tersolisib (LY4064809) and Abemaciclib With Hormone Therapies in Participants With PIK3CA-Mutated Early Breast Cancer (PIKALO-3)
A Phase 2, Open-label, Randomized Study Investigating the Tolerability of Concurrent Versus Staggered Administration of Abemaciclib and Endocrine Therapy With Tersolisib in Patients With HR+, HER2- Node-Positive, PIK3CA-Mutated Early Breast Cancer.
The main purpose of this study is to compare two ways of giving the anti-cancer medicines abemaciclib and hormone therapy with tersolisib in participants with early breast cancer that has a genetic mutation (PIK3CA mutation).
For each participant, the study will last up to 56 weeks and include 12 visits.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Telefonnummer: 1-317-615-4559
- E-post: LillyTrials@Lilly.com
Studera Kontakt Backup
- Namn: Physicians interested in becoming principal investigators please contact
- E-post: clinical_inquiry_hub@lilly.com
Studieorter
-
-
California
-
Los Alamitos, California, Förenta staterna, 90720
- Cancer and Blood Specialty Clinic
-
Huvudutredare:
- Sassan Farjami
-
-
Colorado
-
Lakewood, Colorado, Förenta staterna, 80228
- USO - Rocky Mountain Cancer Centers
-
Huvudutredare:
- Sara Robinson
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30308
- Winship Cancer Institute, Emory University
-
Huvudutredare:
- Manali Bhave
-
-
Massachusetts
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Boston, Massachusetts, Förenta staterna, 02215
- Dana-Farber Cancer Institute
-
Huvudutredare:
- Erica Mayer
-
-
Ohio
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Columbus, Ohio, Förenta staterna, 43212
- Stefanie Spielman Comprehensive Breast Center
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Huvudutredare:
- Robert Wesolowski
-
-
Texas
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Amarillo, Texas, Förenta staterna, 79106
- Texas Oncology - West Texas
-
Huvudutredare:
- Ines Sanchez-Rivera
-
Austin, Texas, Förenta staterna, 78731
- Texas Oncology - Balcones
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Huvudutredare:
- Kathryn Hudson
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San Antonio, Texas, Förenta staterna, 78229-3307
- South Texas Accelerated Research Therapeutics (START)
-
Huvudutredare:
- Amita Patnaik
-
-
Virginia
-
Reston, Virginia, Förenta staterna, 20190
- USO - Virginia Cancer Specialists
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Huvudutredare:
- Isabelle Le
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
-
Have histologically or cytologically confirmed breast cancer, defined as individuals with:
-
early stage, resected, invasive breast cancer without evidence of distant metastasis, and
-
have confirmed hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) status defined by
- Hormone Receptor (HR) status: documented estrogen receptor positive (ER+) and/or progesterone receptor+ tumor, defined as greater than or equal to (≥) 1% of tumor cells stained positive, assessed locally on primary disease specimen, as defined by American Society of Clinical Oncology College of American Pathologists (ASCO/CAP) Guidelines
- HER status: fulfill the requirement of HER2- disease by local testing on primary disease specimen; tumor must be HER2- according to ASCO/CAP guidelines for HER2 testing
-
-
Have evidence of an activating phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) mutation in tumor tissue.
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Must have undergone definitive locoregional therapy, defined as surgery of the primary breast tumor(s), with or without radiation therapy, and/or systemic therapy (neo/adjuvant chemotherapy and or Endocrine Therapy (ET)) per standard guidelines.
-
Individuals with bilateral breast cancer (diagnosis of invasive tumors in both breasts simultaneously or within 6 months of each other) may be eligible if all lesions tested on both sides are HR+ HER2- and adequate surgery has been performed for both breasts.
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Tumor involvement in at least 1 axillary lymph node (ALN).
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≥ ipsilateral positive ALN, OR
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1 to 3 ipsilateral positive ALN and either:
- tumor size ≥5cm, or
- histologic Grade 3 tumor (as defined by a combined score of at least 8 points per the modified Bloom-Richardson grading system or equivalent
-
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Individuals must be randomized within 16 months from the time of definitive breast cancer surgery.
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May have received up to 12 weeks of ET with AIs or tamoxifen until randomization following the last non-ET (surgery, chemotherapy, or radiation), whichever is last.
-
Are willing to follow contraception requirements.
Exclusion Criteria:
-
Have evidence of
- metastatic disease
- inflammatory breast cancer at primary breast cancer diagnosis
- breast cancer recurrence (local, regional, or distant), or
- a history of previous invasive breast cancer
-
Has an established diagnosis of type 1 diabetes mellitus or type 2 diabetes mellitus with Hemoglobin A1c (HbA1c) ≥8 percent (%), fasting plasma glucose ≥140 mg/dL (7.7 mmol/L), or requiring insulin.
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Has a history of malignancy other than breast cancer
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Have active Hepatitis B Virus (HBV)
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Have active Hepatitis C Virus (HCV)
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Have untreated Human Immunodeficiency Virus (HIV) infection
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Have any other active systemic infection requiring system therapy
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Have a history of Kaposi sarcoma or multicentric Castleman disease
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Have a serious cardiac condition
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm A: Abemaciclib and Endocrine Therapy (ET) + Tersolisib - Staggered
Abemaciclib in combination with physician's choice of endocrine therapy (ET). Tersolisib will be added in a staggered approach after 2 cycles of abemaciclib and ET. All drugs will be administered orally. |
Administered orally Administered orally Administered orally Administered orally Administered orally
Andra namn:
|
|
Experimentell: Arm B: Abemaciclib and Endocrine Therapy (ET) + Tersolisib - Concurrent
Abemaciclib and tersolisib will be administered concurrently in combination with physician's choice of ET. All drugs will be administered orally. |
Administered orally Administered orally Administered orally Administered orally Administered orally
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Rate of Participants who Discontinue Tersolisib Due to Treatment Emergent Adverse Events (TEAEs).
Tidsram: Cycle 1 through study completion (estimated as 56 weeks)
|
Cycle 1 through study completion (estimated as 56 weeks)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Duration of Exposure to Study Intervention
Tidsram: Start of study intervention through study completion (estimated as 56 weeks)
|
Study intervention start is defined as Cycle -1 for Arm A and Cycle 1 for Arm B. Arm A includes an additional 8 weeks. |
Start of study intervention through study completion (estimated as 56 weeks)
|
|
Number of Study Intervention Dose Adjustments
Tidsram: Start of study intervention through study completion (estimated as 56 weeks)
|
Study intervention start is defined as Cycle -1 for Arm A and Cycle 1 for Arm B. Arm A includes an additional 8 weeks. |
Start of study intervention through study completion (estimated as 56 weeks)
|
|
Pharmacokinetics (PK): Predose Plasma Concentrations (Cmax) of Tersolisib
Tidsram: Day 15 through study completion (estimated as 56 weeks)
|
Day 15 through study completion (estimated as 56 weeks)
|
|
|
Change from Baseline in Side-Effect Burden as Measured by Functional Assessment of Cancer Therapy - General Item GP5 (FACT-GP5)
Tidsram: Baseline to end of study completion (estimated as 56 weeks)
|
Baseline to end of study completion (estimated as 56 weeks)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 27842
- 2026-526410-87-00 (Ctis)
- J6M-MC-JSGH (Annan identifierare: Eli Lilly and Company)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Tidsram för IPD-delning
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Kriterier för IPD Sharing Access
A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
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